Name/CompanyApproval Dates and Comments
Ceftobiprole Zeftera®
Johnson & Johnson/ Basilea Pharmaceuticals

The US FDA rejected the New Drug Application for this antibiotic
in November 2008. The FDA asked that additional audit work of clinical investigator
sites be conducted and that specific questions related to site monitoring be
addressed. This formulation has been approved in Canada and Switzerland to
treat complicated skin and soft-tissue infections.

IV Iclaprim
Arpida Ltd.

The Therapeutic Products Directorate of Health Canada received, in September
2008, a New Drug Submission for this hospital antibiotic drug candidate for
the treatment of complicated skin and skin structure infections. This dihydrofolate
reductase inbitor has potent bactericidal activity against MRSA and an extended
range of pathogens.

HPV Vaccine
Merck & Co.

The US FDA approved additional indications for this HPV vaccine in September
2008 to include the prevention of vaginal and vulvar cancer caused by HPV types
16 and 18 in girls and women aged 9 to 26 years. The vaccine’s label
has been revised to note that presently available information is insufficient
to support use beyond age 26.

Basilea Pharmaceuticals
The Danish Medicines Agency (DKMA) approved this once-daily oral treatment
in September 2008 for the treatment of adults with severe chronic hand eczema
that is unresponsive to potent topical corticosteroids. Marketing applications
for this product are also under review in Canada and Switzerland.
Atazanavir sulfate
Bristol-Myers Squibb
The US FDA approved the use of this 300mg once daily product in October
2008 to be boosted with ritonavir 100mg once daily as part of a combination
therapy in treatment naïve HIV-1 infected adult patients.

Drug News

In October 2008, Genentech issued a Dear Healthcare Provider letter to inform
potential prescribers of a case of progressive multifocal leukoencephalopathy
(PML) in a 70-year old patient who had received Raptiva® (efalizumab) for
more than 4 years for treatment of chronic plaque psoriasis. The case was recently
reported to the company in late September as part of Genentech’s ongoing
safety monitoring and surveillance program. There are no other cases of confirmed
PML in patients treated with this humanized therapeutic antibody, which is
approved by the US FDA for the treatment of chronic moderate-to-severe plaque
psoriasis in adults 18 years of age or older who are candidates for systemic
therapy or phototherapy. The company will work with the US FDA to update the
prescribing information for Raptiva® and determine if further action is
needed. The Dear Healthcare Provider letter has been posted to the Genentech
web site along with the current package insert that includes Raptiva® safety
information and is available by clicking the Raptiva® link at

The US FDA notified healthcare professionals in November 2008 that it is investigating
new preliminary data regarding a potential increase in the risk of serious
skin reactions, incoluding Stevens-Johnson syndrome and toxic epidermal necrolysis
from phenytoin therapy in Asian patients who are positivie for the human leukocyte
antigen allele HLA-B*1502. This allele occurs almost exclusively in Asian patients
with ancestry from areas such as China, the Philipines, Malaysia, India, and
Thailand. This concern also applies to fosphenytoin because it is a prodrug
that is converted to phenytoin after administration. Because this new data
suggests a possible association between HLA-B*1502 and phenytoin or fosphenytoininduced
SJS/TEN, and because of the known association between phenytoin and SJS/TEN,
healthcare providers should consider avoiding phenytoin and fosphenytoin as
alternatives for carbamazepine in patients who test positive for HLA-B*1502.